Catheter tip electrode assembly and method for fabricating same

ABSTRACT

An electrode assembly for a sensor catheter tip includes a first electrode and a second electrode each having a central axis. The two electrodes are axially aligned and spaced apart along the axis. Each of the first and second electrodes comprises a contact aperture spaced from the center axis, and a contact. element positioned within each of the contact apertures. The center axis of each of the first and second electrodes is substantially aligned, and the contact elements corresponding to each of the first and second electrodes are offset, thereby providing staggered contact points for each respective electrode.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to and is a continuation of U.S.Application Ser. No. 11/435,155, filed May 16, 2006, entitled “CATHETERTIP ELECTRODE ASSEMBLY AND METHOD FOR FABRICATING SAME”, which is adivisional of U.S. application Ser. No. 10/679,568, filed Oct. 6, 2003,entitled “CATHETER TIP ELECTRODE ASSEMBLY AND METHOD FOR FABRICATINGSAME”, the subject matter of both of which are herein incorporated byreference in their entirety.

BACKGROUND OF THE INVENTION

This invention relates generally to manufacturing of medicalinstruments, and, more specifically, to the manufacture of a catheterelectrode assembly for an impedance spectroscopy system.

Impedance spectroscopy has been used to detect ischemia (a condition ofinadequate blood flow and oxygen delivery to a given tissue) inbiological tissues using different instrumental methods. Impedancespectroscopy differs from other impedance measurements (which have longbeen used for a variety of biomedical applications) in that it involvesmultiple measurements over a range of frequencies that as a wholecontain significantly more information of the structural and electricalproperties of the sample.

At least one known impedance spectroscopy system for monitoring tissuedamage in hollow viscous organs includes a sensor catheter and animpedance spectrometer for electrically driving the catheter to obtain acomplex impedance spectrum of tissue proximate the catheter. Thecatheter is configured to be inserted into any hollow viscous organ, andthe catheter includes four Ag/AgCl electrodes positioned on an end tipof the catheter. The electrodes are coaxially spaced apart a shortdistance from one another, and the outer two electrodes inject currentinto the tissue, while the inner two electrodes measure the resultingvoltage. Leads, electrically connected to the electrodes, extend alongthe wall of the catheter tubing or in a lumen portion of the tubing, andterminate at an interface plug suitable for electrical and mechanicalconnection to the impedance spectrometer. Once the catheter is in placein one of a patient's hollow viscous organs, the impedance spectrometercauses the electrodes in the tip of the catheter to inject a currentinto the mucosal tissue at different frequencies, allowing for themeasurement of the tissue's complex impedance spectrum. Analysis of thespectrum determines the extent to which the tissue is damaged. See, forexample, U.S. Patent Application Publication US 2002/0013537.

The construction of the catheter tip assembly for such a system hasproven difficult in a number of aspects. The catheter tip assembly is,for example, typically inserted into the throat or nasal passage of apatient and into a gastrointestinal organ, and the therefore must be ofa relatively small size and have a uniform, high quality surface finish.The tip assembly, however. includes a relatively large number ofcomponent parts which must be assembled and interconnected, including atip, four electrodes, dielectric spacer elements between the electrodes,and. leads attached to each electrode, which can make a uniform surfacefinish difficult to achieve. Additionally, assembly of the manycomponent parts is cumbersome, and separately connecting the electricalleads to the spaced electrodes in a reliable manner is difficult.Managing the wire leads in the constrained internal space of theassembly, which entails threading the wires through the dielectricspacer elements, is especially difficult. These and other difficultiesnot only complicate the tip assembly time and increase manufacturingcosts, but may negatively affect the performance and reliability of theimpedance spectroscopy system when treating critically ill patients.

BRIEF DESCRIPTION OF THE INVENTION

In one embodiment, an electrode assembly for a sensor catheter tip isprovided. The assembly includes a first electrode and a second electrodeeach having a central axis. The two electrodes are axially aligned andspaced apart along the axis. Each of the first and second electrodescomprises a contact aperture spaced from the center axis, and a contactelement positioned within each of the contact apertures. The center axisof each of the first and second electrodes is substantially aligned, andthe contact elements corresponding to each of the first and secondelectrodes are offset, thereby providing staggered contact points foreach respective electrode.

Optionally, the contact elements, of the first and second electrode areoffset approximately 90 degrees from one another. Each of the first andsecond electrodes comprise a disk defined by multiple regions, thecontact element positioned in one of the regions, the other of theregions comprising a lead aperture extending therethrough. Each of thecontact elements have an axial length which is different for each of thecontact elements, and each contact element comprises a tail portionconfigured for soldering or crimping. An overmolded dielectric spacerelement is disposed between the first and second electrodes, and thedielectric spacer element extends at least partially through one of theelectrodes.

In another embodiment, a catheter tip assembly for an impedancespectroscopy system is provided. The assembly comprises a roundeddielectric tip, and a first electrode disk adjacent the tip whichcomprises a body having a contact aperture therethrough. A secondelectrode disk is axially spaced from the first electrode disk, and thesecond electrode comprises a body having a contact aperturetherethrough. The second electrode disk is rotated relative to the firstelectrode disk about a longitudinal axis so that the contact aperturesare circumferentially offset from one another.

In another embodiment, a method of fabricating a catheter tip for animpedance spectroscopy system is provided. The catheter tip includes aplurality of electrodes with a dielectric material positioned betweenadjacent electrodes. Each of the electrodes includes a contact apertureand at least one lead aperture, and the electrodes are electricallyconnected to respective contacts. The method comprises positioning oneof the contacts in contact with each of the electrodes via therespective contact apertures, stacking the electrodes and attachedcontacts, and rotating each electrode relative to the adjacent electrodein the stack so that the contacts are offset from one another in thestack.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of an exemplary tip assembly formed in accordancewith an exemplary embodiment of the present invention and adapted foruse in a sensor catheter assembly for an impedance spectroscopy system.

FIG. 2 is a top plan view of an exemplary electrode disk for the tipassembly shown in FIG. 1.

FIG. 3 is partial cross sectional plan view of an exemplary electrodecontact for the tip assembly shown in FIG. 1.

FIG. 4 is a top plan view in a first stacked position of an electrodeassembly for the tip assembly shown in FIG. 1.

FIG. 5 is a top plan view of the electrode assembly in a second stackedposition.

FIG. 6 is a top plan view of the electrode assembly in a third stackedposition.

FIG. 7 is a top plan view of the electrode assembly in a fourthposition.

FIG. 8 illustrates the electrode assembly at another stage ofmanufacture.

FIG. 9 illustrates the electrode assembly at a further stage ofmanufacture.

FIG. 10 is a partial cross sectional view of the catheter tip assemblyat a final stage of manufacture.

FIG. 11 is a schematic view of a completed catheter tip assembly.

FIG. 12 is a sectional view of an exemplary sump tube for the tipassembly shown in FIGS. 1 and 11.

FIG. 13 is a perspective view of an exemplary electrode disk formed inaccordance with another exemplary embodiment of the present invention.

FIG. 14 is a perspective view of a dielectric spacer element for usewith the electrode disk shown in FIG. 13.

FIG. 15 is a perspective view of an exemplary contact clip for use withthe electrode and dielectric disk shown in FIGS. 13 and 14.

FIG. 16 is an exploded view of an electrode assembly at a first stage ofmanufacture.

FIG. 17 is an exploded view of the electrode assembly shown in FIG. 16at a second stage of manufacture.

FIG. 18 is a perspective view of the electrode assembly shown in FIG. 16at a third stage of manufacture.

FIG. 19 illustrates an exemplary lead wire and contact for the electrodeassembly shown in FIG. 18.

FIG. 20 is an assembly view of the electrode assembly shown in FIGS.16-18 at a fourth stage of manufacture.

FIG. 21 is a perspective view of a completed electrode assembly.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates a tip assembly 100 for a sensor catheter of animpedance spectroscopy system. The tip assembly 100 comprises ahemispherically rounded tip 102. an electrode assembly 104 extendingfrom the tip 102, a connector portion 106 extending from the electrodeassembly 104 opposite the tip 102, and a coupler portion 108 extendingfrom the connector portion 106. As described in detail below, in apreferred embodiment, the tip assembly 100 is fabricated in a series ofmolding operations which ensures reliable electrical interconnection ofthe electrode assembly 104 with a relatively few number of parts incomparison to known catheter tip assemblies. Performance and reliabilityof the tip assembly 100 may therefore be provided at a reduced cost.

In an exemplary embodiment, the electrode assembly 104 of the tipassembly 100 includes four generally cylindrical electrodes 116, 118,120 and 122 which are electrically connected, via respective wires 110(two of which are shown in FIG. 1) to the impedance spectroscopy system.Stacking and rotating of the electrodes, 116 through 122, as describedbelow, provides staggered or offset contact points (not shown in FIG. 1)for each lead wire 110 within the tip assembly 100. The staggeredcontact points facilitate direct connection and routing of electrodecontact elements (not shown in FIG. 1) through the electrode assembly104, as well as convenient attachment of the lead wires 110 for eachrespective electrode 116 through 122 as described below.

The lead wires 110 extend from an end 112 of the coupler portion 108,and a flexible sump tube 114 is provided which can be inserted, togetherwith the tip assembly 100, in any hollow viscous organ. The sump tube114 is sealingly engaged to the tip assembly 100 over the couplerportion 108 such that the coupler portion 108 and lead wires 110 extendthrough a lumen (not shown in FIG. 1) of the sump tube 114 to anelectrical multi-channel connector (not shown) that can be plugged intothe impedance spectrometer portion (not shown) of a known impedancespectroscopy system.

The electrodes 116 through 122 of the electrode assembly 104 function asionic-current-to-electronic-current transducers, such as Ag/AgClelectrodes. It is appreciated, however, that other types of suitableelectrodes could be used without departing from the spirit and scope ofthe invention. The electrodes 116 through 122 are formed substantiallyidentically to one another, and the electrodes 116 through 122 arespaced equally apart from one another along the electrode assembly 104,and are separated by dielectric spacer elements 124, 126, and 128. Theouter diameters of the tip 102 and the electrodes 116 through 122 areabout the same as an outer diameter of the spacer elements 124 through128 and further are about the same as the outer diameter of the sumptube 114 to ensure that a substantially continuous outer surface of thetip assembly is formed. The tip assembly 100 interfaces with the sumptube 114 at a shoulder 130 of the connector portion 106 at an end 132 ofthe sump tube to form a contiguous outer surface of the tip assembly 100and the tube 114 which facilitates insertion of the tip assembly 100 andsump tube 114 into a patient with minimal discomfort.

A signal processing device associated with the spectroscopy system, suchas an appropriately-programmed general purpose computer, processes acomplex impedance spectrum sensed by the electrode assembly 104 todetect tissue damage in a patient. To monitor mucosal damage, a catheterincluding the tip assembly 100 is placed in one of a patient's hollowviscous organs, and current is injected by two of the electrodes 116 and122 at a range of frequencies. The other two electrodes 118 and 120measure the resulting voltage spectrum, which is subsequently processedand analyzed. The spectroscopy system is of the type described in U.S.Patent Application Publication US 2002/0013537, the disclosure of whichis hereby incorporated by reference in its entirety.

While four electrodes 116 through 122 are illustrated in the exemplaryembodiment, it is appreciated that only two of the four electrodes maybe provided in an alternative embodiment without departing from thescope of the present invention. In a two electrode embodiment, eachelectrode would be used for both current source and voltage measurement.Additionally, in a two electrode embodiment, only one of the dielectricspacer elements 124 through 128 would be employed in between the twoelectrodes. It is further contemplated that more than four electrodesmay be provided in still another embodiment.

FIG. 2 is a top plan view of an exemplary electrode disk 140 which maybe employed in the electrode assembly 104 (shown in FIG. 1) of the tipassembly 100 (shown in FIG. 1) as any of the electrodes 116, 118, 120and 122 (all shown in FIG. 1). The disk 140 includes a body 142 having acenter 144 corresponding to a central axis of the disk, two radiallyextending spokes 146 and 148 extending from the center 144, and asubstantially cylindrical outer surface 150. The body 142 furtherincludes substantially flat and parallel end planes or surfaces 152(only one of which is visible in FIG. 2) which are perpendicular to thecentral axis. The spokes 146 and 148 extend substantially perpendicularto one another in one embodiment; and centerlines 147 and 149 througheach of the spokes 146 and 148 intersect at the center 144 of the disk140 and define four substantially equal regions or quadrants of the disk140. A circular contact aperture 154 extends between the opposite endplanes of surfaces 152 in one of the quadrants, and the remaining threequadrants each include a lead aperture 156. As illustrated in FIG. 2,each lead aperture 156 is significantly larger than the contact aperture154, and each lead aperture 156 includes a curved edge 158 extendingparallel to the cylindrical outer surface 150 and substantially straightedges 160 extending substantially parallel to one of the spokes 146 and148. Each of the lead apertures 156 therefore has a rounded triangularshape or profile in an exemplary embodiment. It is recognized, however,that a variety of shapes of lead apertures 156 may be employed infurther and/or alternative embodiments of the invention.

In use, and as further described below, a contact element 170 ispositioned in the contact aperture 154. The contact element is attachedto a respective wire lead 110 (shown in FIG. 1) as the tip assembly 100(shown in FIG. 1) is manufactured. The lead apertures 156 facilitatepassage of the contact element through the electrode assembly 104 (shownin FIG. 1) and further facilitates molding of the dielectric spacerelements 124, 126 and 128 (shown in FIG. 1) during fabrication of thetip assembly 100.

FIG. 3 is partial cross sectional plan view of an exemplary electrodecontact element 170 in the form of an elongated contact pin for the tipassembly 100 (shown in FIG. 1). In an exemplary embodiment, the contactpin 170 includes a body 172 having a tapered leading end 174, asubstantially cylindrical shaft portion 176, and a hollow, cup like tailportion 178 forming a passage 180 which receives an end (not shown) ofone of the lead wires 110 (shown in FIG. 1). In one embodiment, the tailportion 178 and the passage 180 form a solder cup for electricallyconnecting stripped conductors of a lead wire 110 via a known solderingprocess. It is appreciated, however, that other electrical connectiontechniques may be employed in lieu of soldering to establish anelectrical connection between the contact pin 170 and a lead wire 110 inalternative embodiments.

The electrode assembly 104 according to the invention includes onecontact pin 170 for each electrode in the assembly, and hence in theillustrated embodiment, the electrode assembly 104 includes fourseparate contact pins 170, and each contact pin 170 corresponds to oneof the electrodes 116, 118, 120 and 122. In a two electrode embodiment,two contact pins 170 would be employed.

The shaft portion 176 of each contact pin 170 is dimensioned for pressfitting a contact pin 170 into the contact aperture 154 (shown in FIG.2) of each electrode 116 through 122 (shown in FIG. 1), and hence in theillustrated embodiment, one contact pin 170 is press fit into thecontact aperture 154 of each electrode 116 through 122. Each contact pin170 has an axial length L_(x) measured from a tip of the leading end 174to an end 182 of the tail portion 178, and L_(x) corresponds to an axialdistance from a connection point 220 (shown in FIG. 11) in the connectorportion 106 (shown in FIG. 11) of the tip assembly 100 to the respectiveelectrode 116 through 122. That is, L_(x) varies depending upon whichelectrode 116, 118, 120 or 122 the contact pin 170 engages in theelectrode assembly 104. Referring, for example, to FIG. 11, from theshortest contact length L_(x) to the longest contact length L_(x) in afour electrode embodiment, the first electrode 122 closest to theconnection point 220 has a length L₁, the next closest electrode 120 hasa length L₂, the next closest electrode 118 has a length L₃, and thefarthest electrode 116 has a length L₄. Comparing FIG. 11 and FIG. 3, itmay be seen that the difference in length L_(x) of the contact pins 170is principally the different length of the shaft portions 176 of thecontact pins 170.

By engaging the contact pins 170 to the contact apertures 154 of theelectrodes 116 through 122, and further by stacking and rotating theelectrodes as described below, reliable electrical connection may beestablished between the respective electrodes 116 through 122, thecontact pins 170 and the lead wires 110 (shown in FIG. 1).

FIGS. 4-7 illustrate a stacking and rotating procedure for fabricatingthe electrode assembly 104 (shown in FIG. 1). FIG. 4 shows the electrode116 having a press fit contact pin 170 engaged to contact aperture 154.The lead openings 156 of the electrode 116 are open and clear of anycontact pins 170.

FIG. 5 illustrates the electrode 116 and the electrode 118 in a stackedrelation, with the electrode 118 situated underneath and substantiallyaxially aligned with the electrode 116. That is, the centers 144 (shownin FIG. 2) of each of the electrodes 116 and 118 are substantiallyaligned along a common axis. The electrode 118 is rotated 90 degrees inthe direction of arrow A about the center axis relative to the electrode116. As such, the contact aperture 154 of the electrode 118 is locatedbeneath one of the lead apertures 156 of the electrode 116, and theleading end 174 of a contact pin 170 engaged to the electrode 118 ispositioned generally 90 degrees about the center axis from the contactaperture 154 of the electrode 116. The lead apertures 156 on the lowerportion of the electrodes 116 and 118 in FIG. 5 are substantiallyaligned with one another, and the contact pin 170 coupled to theelectrode 116 extends through the remaining lead aperture 156 (notvisible in FIG. 5) positioned underneath the contact aperture 154 of theelectrode 116.

FIG. 6 illustrates the electrode 116, the electrode 118, and theelectrode 120 in a stacked relation, with the electrode 120 situatedunderneath and substantially axially aligned with the electrodes 116 and118. That is, the centers 144 (shown in FIG. 2) of each of theelectrodes 116, 118, and 120 are substantially aligned along a commonaxis. The electrode 120 is rotated 90 degrees from the electrode 118 inthe direction of arrow A about the center axis of the electrodes 116 and118. As such, the contact aperture 154 of the electrode 120 is locatedbeneath one of the lead apertures 156 of the electrode 118, and theleading end 174 of a contact pin 170 engaged to the electrode 118 ispositioned generally 90 degrees about the center axis from the contactaperture 154 of the electrode 118. The lead apertures 156 on the lowerleft hand portion of the electrodes 116, 118, and 120 in FIG. 6 aresubstantially aligned with one another. The contact pin 170 coupled tothe electrode 116 extends through lead apertures 156 (not visible inFIG. 6) of each of the electrodes 118 and 120 positioned underneath thecontact aperture 154 of the electrode 116. The contact pin 170 coupledto the electrode 118 extends through one of the lead apertures 156 (notvisible in FIG. 6) of the electrode 120 positioned underneath thecontact aperture 154 of the electrode 118.

FIG. 7 illustrates the electrodes 116, 118, 120 and 122 in a stackedrelation, with the electrode 122 situated underneath and substantiallyaligned with the electrodes 116, 118 and 120. That is, the centers 144(shown in FIG. 2) of each of the electrodes 116, 118, 120 and 122 aresubstantially axially aligned along a common axis. The electrode 122 isrotated 90 degrees from the electrode 120 in the direction of arrow Aabout the center axis of the electrodes 116, 118 and 120. As such, thecontact aperture 154 of the electrode 122 is located beneath one of thelead apertures 156 of the electrode 120, and the leading end 174 of acontact pin 170 engaged to the electrode 120 is positioned generally 90degrees about the center axis from the contact aperture 154 of theelectrode 120. The contact pin 170 coupled to the electrode 116 extendsthrough lead apertures 156 (not visible in FIG. 7) of each of theelectrodes 118, 120 and 122 positioned underneath the contact aperture154 of the electrode 116. The contact pin 170 coupled to the electrode118 extends through the lead apertures 156 (not visible in FIG. 7) ofthe electrodes 120 and 122 positioned underneath the contact aperture154 of the electrode 118. The contact pin 170 coupled to the electrode120 extends through the lead aperture 156 (not visible in FIG. 7) of theelectrode 122 positioned underneath the contact aperture 154 of theelectrode 120.

In the stacked orientation of FIG. 7, the electrode assembly 104 may besecured together in a molding process. The contact pins 170 of therespective electrodes 116 through 122 are positioned 90 degrees aboutthe center axis from one another in the stack, and the contact pins 170extend through the lead apertures 156 of subsequent electrodes in thestack. The stacked electrodes 116 through 122 and associated contactpins 170 may be placed in a mold (not shown) and the stack is overmoldedwith a dielectric material according to a known process to form the tip102 (shown in FIG. 1) and the spacer elements 124, 126 and 128 (shown inFIG. 1). In one embodiment, the outer surfaces 150 of the electrodes 116through 122 are secured in the mold within pockets or channels in themold, and the dielectric material flows through the lead apertures 156and between the respective electrodes 116, 118 and 120, thereby formingan integral electrode assembly 104 wherein the dielectric spacerelements 124, 126, and 128 are intimately formed with the stackedelectrodes 116 through 122 and the associated contact pins 170.

FIG. 8 illustrates the electrode assembly 104 at a stage of manufacturejust after overmolding of the stacked and rotated electrodes 116 through122. The outer surface 150 of each of the electrodes 116 through 122extends beyond an outer surface 230 of the molded tip 102 and thedielectric spacer elements 124 through 128 due to the configuration ofthe mold. The rounded tip 102 is molded on one end of the electrodeassembly 104 adjacent the electrode 116, and the tail portions 178 ofthe contact pins 170 extend from an opposite end 232 of the electrodeassembly 104 proximate the electrode 122. The respective tail portions178 of each of the contact pins 170 connected to each of the electrodes116, 118, 120 and 122 are therefore exposed for connecting the leadwires 110 (shown in FIG. 1) to the contact pins 170.

FIG. 9 illustrates the electrode assembly 104 at a subsequent stage ofmanufacture wherein the outer surfaces 150 of the electrodes 116, 118,120, and 122 are machined such that the outer surfaces 150 of theelectrodes, together with the outer surfaces 230 of the dielectricspacer elements 124, 126 and 128, form a substantially smooth andcontinuous outer surface over the integral electrode assembly 104. Thelead wires 110 (shown in FIG. 1) are connected to each of the exposedrespective tail portions 178 of the contact pins 170 by, for example, aknown soldering process.

After the lead wires 110 are attached to the contact pins 170, theelectrode assembly 104 is placed in a mold, and the connector portion106 (shown in FIG. 1) and the coupler portion 108 (also shown in FIG. 1)are overmolded to form the tip assembly 100 (shown in FIG. 1).

FIG. 10 is a partial cross sectional view of the tip assembly 100 afterthe electrode assembly 104 is overmolded to form the connector portion106 which encases the soldered contact pins 170 and the coupler portion108 which extends over the lead wires 110. The coupler portion 108extends from a shoulder 130 at the end of the connector portion 106which forms a step between the outer surface 230 of the electrodeassembly 104 and an outer surface 240 of the coupler portion 108. Thelead wires 110 are gathered together and extend through a centralpassage 242 in the coupler portion 108. The passage 242 is dimensionedto receive the wires 110 corresponding to each of the contact pins 170in the electrode assembly 104.

FIG. 11 is a schematic view of a completed tip assembly 100. Each of theelectrodes 116 through 122 are electrically connected to one of therespective contact pins 170 within the respective contact apertures 154and extending for axial lengths L₁ through L₄ in the electrode assembly104. The dielectric spacer elements 124, 126 and 128, and also the tip102 are molded over the electrodes 118 through 122. The wire leads 110are coupled to the respective tail portions 178 of each of the contactpins 170, and the connector portion 106 and the coupler portion 108 aremolded over the contact points 220 and the lead wires 110 to completethe assembly 100.

Summarizing, the assembly 100 is fabricated by pressing fitting thecontact pins 170 to the electrodes 116 through 122; stacking androtating the electrodes 116 through 122 and the associated contact pins170 with the contact pins 170 axially offset from one another andextending through lead apertures 156 (shown in FIGS. 2 and 4-7) ofsubsequent electrodes in the stack; overmolding the stacked electrodesto form the tip 102 and the dielectric spacer elements 124, 126, and 128as illustrated in FIG. 8; machining the electrodes to form a smooth andcontinuous outer surface on the electrode assembly 104 as shown in FIG.9; connecting the lead wires 110 to the tail portions 178 of theelectrode assembly; and overmolding the electrode assembly 104 and thelead wires to form the connector portion 106 and the coupler portion108. Once completed, the tip assembly 100 may be tested to ensure properoperation of the electrode assembly 104 before use.

The above described tip assembly 100 and method of fabrication providesa number of advantages over known tip assembly constructions. Forexample, the staged molding of the tip assembly to form the dielectricspacer elements 124, 126 and 128 and the connector and coupler portions106 and 108 eliminates separately provided components and reduces thenumber of parts in the tip assembly. The substantially identicallyformed electrodes may be manufactured in bulk, and the contact pins 170are of a uniform design albeit different lengths. Rotating theelectrodes 116 through 122 and providing the contact pins 170 avoidsdifficulties in connecting the electrodes to the lead wires 110, therebyreducing assembly time and costs. Reliable and consistent electricalconnections for the electrodes 116 through 122 are therefore achieved ina relatively low cost and straightforward manufacturing process.

FIG. 12 is a sectional view of an exemplary sump tube 114 for the tipassembly 100 (shown in FIG. 11). In one embodiment, the sump tube 114includes a cylindrical outer surface 250 having an outer diametersubstantially equal to an outer diameter of the electrode assembly 104(shown in FIG. 11), a first passage or lumen 252 extending through thetube 114, and a second lumen 254 extending through the tube 114. Thefirst lumen 252 is substantially a cylindrical passage having acomplementary shape to the coupler portion 108 (shown in FIG. 11) of thetip assembly 100 and dimensioned to receive the coupler portion 108therein. The lumen 252 is inserted over the coupler portion 108 and thetube 114 is sealed to the coupler portion 108 at one end thereof. Thelead wires 110 extend through the lumen 252 and are connected toexternal equipment on an opposite end for transmitting and receivingsignals to and from the electrodes. It is recognized that the couplerportion 108 and the lumen 252 may be formed into a variety ofalternative complementary shapes in lieu of a cylindrical shape inalternative embodiments.

The second lumen 254, sometimes referred to as a primary lumen, isprovided for feeding/sump tube purposes or as another type of lifesupport. When placed in fluid communication with an organ, the primarylumen 254 may be used, for example, for passage of food to a patient,for drainage of fluid from the patient, or other purposes. It isappreciated that the primary lumen 254 may have a variety of shapes invarious embodiments.

FIG. 13 is a perspective view of an exemplary electrode disk 300 formedin accordance with another exemplary embodiment of the present inventionand which may be used to construct a tip assembly (not shown in FIG. 12)according to another method. The electrode 300 includes a centralaperture 302, four substantially equally spaced contact apertures 304positioned around the central aperture 302, and one positioning aperture306 located between two of the contact apertures 304. The electrode 300functions as an ionic-current-to-electronic-current transducer, such asan Ag/AgCl electrode, although it is appreciated that another type ofsuitable electrode could be used without departing from the spirit andscope of the invention.

FIG. 14 is a perspective view of a dielectric spacer element 320. Thespacer element 320 includes a central aperture 322, four substantiallyequally spaced contact apertures 324 positioned around the centralaperture 322, and one positioning protrusion or peg 326 located betweentwo of the contact apertures 324. The peg 326 is dimensioned for pressfit insertion into the positioning aperture 306 (shown in FIG. 13) ofthe electrode 300 to mate the electrode 300 to the spacer element 320.The spacer element 320 is fabricated from a dielectric materialaccording to known processes and techniques.

FIG. 15 is a perspective view of an exemplary contact element in theform of a contact clip 340 including a rim 342 and a number of inclinedcontact fingers 344 extending from the rim 342 and converging toward oneanother. The rim 342 is dimensioned for press fit insertion into one ofthe contact apertures 304 of the electrode 300 (shown in FIG. 13) withthe contact fingers 344 extending from one side of the electrode 300.The contact clip 340 may be fabricated from a conductive materialaccording to known techniques.

FIG. 16 is an exploded view of an electrode assembly 350 at a firststage of manufacture wherein a number of electrodes 300 are stacked withdielectric spacer elements 320 sandwiched between the electrodes. Apositioning peg 326 of a spacer 320 is inserted into the positioningaperture 306 of the adjacent electrode 300, and each of the electrodes300 is rotated about 90 degrees about the center axis from the adjacentelectrode 300 in the stack. The respective spacer elements 320 areaccordingly rotated so that the pegs 326 may be engaged to therespective electrodes 300. The contact apertures 304 and 324 of theelectrodes 300 and the spacer elements 320 are substantially alignedwith the adjacent electrodes/spacer elements to form contact passagesthrough the stack. The central apertures 302 and 322 of the electrodes300 and the spacer elements 320 are substantially aligned with theadjacent electrodes/spacer elements to form a continuous center passagethrough the stack.

A contact clip 340 (shown in FIG. 15) is inserted into each of theelectrodes 300 in one of the contact apertures 304 such that, when theelectrodes are stacked and rotated, the contact clips 340 are positioned90 degrees from one another within the stack. The contact fingers 344 ofthe clips 340 extend through the contact apertures 324 of adjacentspacer elements 320.

FIG. 17 is a view of the electrode assembly 350 at a second stage ofmanufacture wherein a separately formed tip 360 is provided having arounded head 362, a central post 364 extending therefrom, and apositioning peg 366. The post 364 is inserted through the centralapertures 302 and 322 of the electrodes 300 and the spacer elements 320,and the peg 366 is inserted into the positioning aperture 306 in theadjacent electrode 300. Once the tip 360 is coupled to the electrodeassembly 350, the electrode assembly 350 may be placed in a mold andovermolded to form a connector portion (not shown in FIG. 17) on an endof the electrode assembly 350 opposite the tip 360.

FIG. 18 is a perspective view of a tip assembly 370 after the electrodeassembly 350 is molded to form a connector portion 372. The connectorportion includes contact apertures 374 extending through the connectorportion 372 and aligning with the contact apertures of the electrodeassembly 350. The post 364 (shown in FIG. 17) of the tip 360 is inintimate contact with and secured to the connector-portion 374 to holdthe tip assembly together.

FIG. 19 illustrates an exemplary lead wire and contact assembly 380including a lead wire 382 and a contact 384 which is crimped to theconductors of the wire 384. The contacts 384 are shaped for engagementwith the fingers 344 (shown in FIG. 15) of the contact clips 340 (shownin FIG. 15).

FIG. 20 is a perspective view of a number of wire and contact assemblies380 extended through a lumen 390 of a flexible tube 392, and thecontacts 384 inserted into the contact apertures of the tip assembly370. The wires 382 are inserted into the tip assembly 370 until therespective contact 384 engages one of the contact clips 340 in theelectrode assembly 350.

FIG. 21 illustrates a completed catheter assembly 400 including the tipassembly 370 and the tube 392 coupled thereto. A second lumen 400 isprovided in the tube as desired. The lead wires 382 extend through thefirst lumen 390 of the tube 392 and to external equipment to transmitand receive signals from the electrodes 300.

Summarizing, the assembly 370 is fabricated by pressing fitting thecontact clips 340 to the electrodes 300; rotating the electrodes 300 andthe associated contact clips 340 with the contact clips 340 offset fromone another and extending through the contact apertures 324 of thespacer elements 320 in the stack; stacking the electrodes 300 and thespacer elements 320 such that the dielectric spacer elements 320 aresandwiched between the electrodes 300; inserting a tip 360 into thestacked electrodes; overmolding the stacked electrodes to form theconnector portion 372 and to secure the stack to the tip 360; crimpingthe contacts 384 to the lead wires 382; and inserting the lead wires 382into the contact apertures in the stack until the contacts engage thecontact clips 340. Once completed, the tip assembly 370 may be tested toensure proper operation of the electrode assembly 350 before use.

The above described tip assembly 370 and method of fabrication providesa number of advantages over known tip assembly constructions. Forexample, the substantially identically formed electrodes and spacerelements may be manufactured in bulk at a relatively low cost. Rotatingthe electrodes and providing the contact clips avoids difficulties inconnecting the electrodes to the lead wires, and engaging the crimpedcontacts to the contact clips is easily accomplished. Reliable andconsistent electrical connections for the electrodes are thereforeachieved in a relatively low cost and straightforward manufacturingprocess.

While the invention has been described in terms of various specificembodiments, those skilled in the art will recognize that the inventioncan be practiced with modification within the spirit and scope of theclaims.

1.-16. (canceled)
 17. A method of fabricating a catheter tip for animpedance spectroscopy system, the catheter tip including a plurality ofelectrodes with a dielectric material extending between adjacentelectrodes, each of the electrodes including a contact aperture and atleast one lead aperture, the electrodes electrically connected torespective contacts, said method comprising: press fitting one of thecontacts to each of the electrodes via the respective contact apertures;stacking the electrodes and attached contacts; and rotating eachelectrode relative to the adjacent electrode in the stack so that thecontacts are staggered from one another in the stack.
 18. A method inaccordance with claim 17 wherein the contacts have different lengths andeach of the electrodes has a lead opening, said method furthercomprising arranging the electrodes such that each respective contact inthe stack of electrodes extends through each of the respective leadopenings of electrodes having a shorter contact in the stack.
 19. Amethod in accordance with claim 17 further comprising injection moldingthe electrodes with a dielectric material, thereby forming dielectricspacer elements between the electrodes.
 20. A method in accordance withclaim 17 further comprising stacking dielectric spacer elements betweeneach of the electrodes such that a positioning peg of each spacerelement is received within at least one adjacent electrode.
 21. A methodin accordance with claim 18 further comprising attaching a lead to eachrespective contact.
 22. A method in accordance with claim 18, theassembly including a tip adjacent a first stacked electrode, said methodfurther comprising overmolding a connector portion opposite the tip. 23.A method in accordance with claim 18 wherein said stacking theelectrodes and attached contacts comprises stacking electrodes anddielectric spacer elements so that the spacer elements are sandwichedbetween the electrodes.
 24. A method in accordance with claim 18 furthercomprising inserting a portion of the tip into the stacked electrodes,and overmolding the stacked electrodes to secure the tip to theelectrodes.
 25. A method in accordance with claim 18 wherein said pressfitting one of the contacts to each of the electrodes via the respectivecontact apertures comprises press fitting a rim of a contact clip to thecontact apertures, whereby a finger extending from the rim extendsthrough the aperture.
 26. An electrode assembly for a sensor cathetertip, said assembly comprising: a first electrode and a second electrode,each electrode comprising a body having a center axis, each electrodecomprising a contact point radially spaced from the center axis andradially offset with one another, each electrode comprising at least oneaperture radially spaced from the center axis, the electrodes beingaxially aligned and spaced apart along the center axis; and a contactelement connected to each contact point, each contact element havingfingers configured to be spread apart when mated with a lead wire suchthat the fingers engage, and are electrically coupled to, thecorresponding contact point.
 27. An electrode assembly in accordancewith claim 26, wherein said contact points of said first and secondelectrodes are offset approximately 90 degrees from one another.
 28. Anelectrode assembly in accordance with claim 26, wherein each of saidfirst and second electrodes comprise a disk defined by multiple regions,said contact point positioned in one of said regions, the other of saidregions comprising the aperture extending therethrough.
 29. An electrodeassembly in accordance with claim 26, further comprising a dielectricspacer element disposed between said first and second electrodes.
 30. Acatheter tip assembly for an impedance spectroscopy system, saidassembly comprising: a rounded dielectric tip; a first electrode diskadjacent said tip, said first electrode disk comprising a body having acontact aperture therethrough and a lead aperture therethrough, whereinthe contact aperture is configured to receive a first contact by a pressfit to electrically and mechanically couple the first contact to thefirst electrode disk; a second electrode disk axially spaced from saidfirst electrode disk, said second electrode comprising a body having acontact aperture therethrough and a lead aperture therethrough, whereinthe contact aperture is configured to receive a second contact by apress fit to electrically and mechanically couple the second contact tothe second electrode disk, wherein said second electrode disk is rotatedrelative to said first electrode disk about a longitudinal axis so thatsaid contact aperture of said first electrode disk is axially alignedwith said lead aperture of said second electrode disk; and a dielectricspacer element positioned between said first and second electrode disks,said dielectric spacer element having at least one peg extendingtherefrom, the at least one peg being received within at least one ofthe first and second electrode disks.
 31. A catheter tip assembly inaccordance with claim 30, wherein the dielectric spacer element includesa plurality of openings therethrough, the openings being aligned withthe lead apertures and the contact apertures.
 32. A catheter tipassembly in accordance with claim 30, wherein each of the first andsecond electrode disks include positioning apertures, the at least onepeg being received in the positioning aperture of the second electrodedisk.
 33. A catheter tip assembly in accordance with claim 30, whereinthe tip includes a positioning peg, the positioning peg of the tip beingreceived within the first electrode disk to position the first electrodedisk with respect to the first electrode disk.
 34. A catheter tipassembly in accordance with claim 30, further comprising a thirdelectrode disk and a fourth electrode disk, said third and fourthelectrode disks substantially identical to said first and secondelectrode disks, wherein each of said first, second, third and fourthelectrode disks are circumferentially rotated relative to one another.35. A catheter tip assembly in accordance with claim 30, wherein thefirst and second contacts comprise a contact clip at an end thereof,said contact clip of each of said first and second contacts press fitinto a respective one of said first and second contact apertures, one ofsaid first and second contacts extending through a lead aperture in oneof said first and second electrode disks.
 36. A catheter tip assembly inaccordance with claim 30, further comprising first and second contactsinserted through said first and second contact apertures, each of saidfirst and second contacts having a different axial length.